Patient-reported Outcomes After Metabolic Surgery Versus Medical Therapy for Diabetes: Insights From the STAMPEDE Randomized Trial
Open accessAbstract
OBJECTIVE: The aim of this study was to investigate the long-term effects of medical and surgical treatments of type 2 diabetes mellitus (T2DM) on patient-reported outcomes (PROs). BACKGROUND: Robust data on PROs from randomized trials comparing medical and surgical treatments for T2DM are lacking. METHODS: The Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial showed that 5 years after randomization, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) were superior to intensive medical therapy (IMT) alone in achieving glycemic control in patients with T2DM and obesity. A subset of 104 patients participating in the STAMPEDE trial were administered two generic health-related quality of life (QoL) questionnaires (RAND-36 and EQ-5D-3L) and a diabetes-specific instrument at baseline, and then on an annual basis up to 5 years after randomization. RESULTS: On longitudinal analysis, RYGB and SG significantly improved the domains of physical functioning, general health perception, energy/fatigue, and diabetes-related QoL compared with IMT group. In the IMT group, none of the QoL components in the generic questionnaires improved significantly from baseline. No significant long-term differences were observed among the study groups in measures of psychological and social aspects of QoL. On multivariable analysis, independent factors associated with improved general health perception at long-term included baseline general health (P < 0.001), insulin independence at 5 years (P = 0.005), RYGB versus IMT (P = 0.005), and SG versus IMT (P = 0.034). Favorable changes following RYGB and SG were comparable. CONCLUSIONS: In patients with T2DM, metabolic surgery is associated with long-term favorable changes in certain PROs compared with IMT, mainly on physical health and diabetes-related domains. Psychosocial well-being warrants greater attention after metabolic surgery.
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In the STAMPEDE trial, metabolic surgery was associated with improvements in patient-reported outcomes related to physical health, but measures of social and psychological quality of life did not improve.
“In the Surgical Treatment and Medications Potentially Eradicate Diabetes Ef fi ciently (STAMPEDE) trial, metabolic surgery was also associated with improvements in patient-reported outcomes related to physical health; however, measures of social and psychological quality of life did not improve (140).”
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- Authors
- Aminian, A., Kashyap, S. R., Wolski, K. E., Brethauer, S. A., Kirwan, J. P., Nissen, S. E., Bhatt, D. L., & Schauer, P. R.
- Affiliations
- Cleveland Clinic (US)
- The Ohio State University Wexner Medical Center (US)
- Pennington Biomedical Research Center (US)
- Brigham and Women's Hospital (US)
- Corresponding author
- Aminian, Ali
- ORCID
- Venue
- Annals of Surgery
- Published
- 2021-06-16
- Volume
- 274
- Issue
- 3
- Pages
- 524-532
- ISSN
- 0003-4932 (ISSN-L)
- 1528-1140
- PMC
- PMC8373787
- OpenAlex
- W3172161076
- Cited by
- 50
- References
- 28
- Citations by year
- 2026: 17 · 2025: 9 · 2024: 8 · 2023: 6 · 2022: 8 · 2021: 2
- FWCI
- 5.63
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Annals of Surgery (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Civil War Book Review (submittedVersion)
- Funders
- National Institute of General Medical Sciences (U54GM104940)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK089547)
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Minimally Invasive Surgical Techniques
- Keywords
- type 2 diabetes, metabolic surgery, bariatric surgery, Roux-en-Y gastric bypass, sleeve gastrectomy, intensive medical therapy, patient-reported outcomes, health-related quality of life, diabetes-specific quality of life, obesity, insulin independence, psychosocial well-being, STAMPEDE trial
- MeSH terms
- Patient Reported Outcome Measures, Diabetes Mellitus, Type 2, Female, Gastrectomy, Humans, Hypoglycemic Agents, Male, Middle Aged, Obesity, Morbid, Quality of Life, Gastric Bypass, Bariatric Surgery
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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